Advice Pool - Legal

The claimant in the case of LG Phillips Co Ltd v Tatung (UK) Ltd and Others [2006], held a UK patent for mounting a flat panel display device within a two-part housing, which could be incorporated into products such as laptops or free standing computer monitors. The paten

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

t was principally directed at LCD displays for laptops. The claimant brought proceedings against three defendants in the patent county court. It was alleged that the defendants had infringed the patent through the creation of a closed circuit television monitor. The defen

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

dants denied infringement, and actually counterclaimed for the revocation of the patent in question on the grounds of anticipation, obviousness and insufficiency.

The claimant then sought to have one of the patent claims amended in order to meet part of the defendant’s c

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ase for revocation. The claimant argued that their action would fail if the courts did not allow the proposed amendments. However, the defendants submitted that by allowing the amendments to take place, additional matter would be added to the patent contrary to s.76 of th

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

e Patents Act 1977 (“the Act”).

The first proposed amendment meant the removal of the affixation of the module to the front housing. In the original patent, there was no mention on how the module would be attached. The claimant submitted that by making this amendment no

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

additional matter would be added to the patent because in at least one incarnation of the invention, the notion that “the module should not be affixed to the front housing” had been disclosed in the product specification.

The second proposed amendment meant that the fast

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

enings would be behind the flat panel display. This feature appeared in a drawing of one of the preferred embodiments of the invention, but was otherwise unidentified. In the original patent, no mention of this feature having inventive significance had been made.

The jud

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ge held that the amendments should not be allowed as they constituted additional matter contrary to s.76. He therefore dismissed the claim for infringement and allowed the case for revocation on the ground that the claimant had conceded that if the amendments were not mad

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

e, their action would fail. The claimants then appealed to the court of appeal.

Their appeal was dismissed for the following reasons:

§ If the specification disclosed distinct sub-classes of the overall inventive concept, then it should be possible to amend down

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

to one of those sub-classes. However, in this case the amendments which were sought were only disclosed in a specific context and were not disclosed as having any inventive significance. Introducing them into a claim would have deprived them of that context, meaning tha

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

t the amendments were not suitable to be added to the claim. This is a process called ‘intermediate generalisation’. This is evidenced more specifically in the second amendment the claimant applied for. The second amendment tried to add an otherwise unidentified feature w

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

hich had only been shown in a drawing. There was no suggestion that the feature had any inventive significance, and the amendment did not wish to attach any other features displayed in that drawing. This is an excellent example of intermediate generalisation, which is not

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

permitted.

§ It was held that the Act was seeking to prevent the owner of a patent from amending a claim to such an extent that they were effectively seeking to protect a different invention to the one in the original application. Therefore, provided the inventio

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

n in the amended claim was disclosed in the original application when read as a whole, it would not offend s.76 of the Act. Where the amendment included a disclaimer which narrowed the claim, it was held that a specific disclaimer did not ‘add matter’ if it was inserted i

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

nto a claim to avoid an 'accidental' anticipation, but it did ‘add matter’ if it was inserted to avoid a 'non-accidental' anticipation. An ‘accidental’ anticipation is one in which a disclosure relating to a remote technological field is made. It can also arise where the

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

subject matter concerned does not help to solve the problem addressed by the patent in question. In the case in question, the first amendment either sought to add a feature to the patent which was not addressed specifically anywhere before, or it sought to add a disclaime

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

r for products which had all the features of the claim save that the module was fixed to the front housing. If the first analysis was correct, then the amendment would be deemed to add new inventive significance to the patent and would offend the rule on adding matter. If

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

the second analysis was correct, then the amendment was effectively a disclaimer included for the purpose of preventing the claim from extending to an item of prior art. It would be difficult to establish that the prior art was in a remote technological field.

The judge

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

was therefore right to have disallowed both amendments.

If you require further information contact us at enquiries@rtcoopers.com. Visit http://www.rtcoopersiplaw.com or http://www.rtcoopers.com/practice_intellectualproperty.php

© RT COOPERS, 2007. This Briefing Note d

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

oes not provide a comprehensive or complete statement of the law relating to the issues discussed nor does it constitute legal advice. It is intended only to highlight general issues. Specialist legal advice should always be sought in relation to particular circumstances.

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.advicepool.org.ua/article/130741/advicepool-Intellectual-Property-Law--Patent-Infringement--Patent-Law--Amendments-Disallowed.html">Intellectual Property Law – Patent Infringement - Patent Law – Amendments Disallowed</a>

BB link (for phorums):
[url=http://www.advicepool.org.ua/article/130741/advicepool-Intellectual-Property-Law--Patent-Infringement--Patent-Law--Amendments-Disallowed.html]Intellectual Property Law – Patent Infringement - Patent Law – Amendments Disallowed[/url]

Color drives emotions and emotions are the most important factor in decision-making.

Obtaining a debt consolidation loan could be the only way to rebuild your credit and of getting out of financial strife.

Tags

Links

Advice Pool - Intellectual Property Law – Patent Infringement - Patent Law – Amendments Disallowed

Related Articles: